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General MedicationsORALGeneric

DROSPIRENONE

DROSPIRENONE

Standard Dose
3.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview DROSPIRENONE is listed in Drugs@FDA under application 216285 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient DROSPIRENONE Form and strength TABLET, CHEWABLE;ORAL - 3.5MG Sponsor EXELTIS USA INC Submission history Latest submission status date: 2022-12-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview DROSPIRENONE is listed in Drugs@FDA under application 216285 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient DROSPIRENONE Form and strength TABLET, CHEWABLE;ORAL - 3.5MG Sponsor EXELTIS USA INC Submission history Latest submission status date: 2022-12-19 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.